Gabapentin
- Product NDC
- 33358-154
- 11-digit product format
- 333580154
- Labeler code
- 33358
- Product ID
- 33358-154_1b9a1aa4-17bf-4f42-9d84-b9872e9b5c10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RxChange Co.
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2014-11-09
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33358-154-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-91c9-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 33358-154-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-91c9-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33358-154-00 | Gabapentin | 100 in 1 BOTTLE | CAPSULE | 100 | 1 | |
| 33358-154-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33358-154-00 | EA - Each | 33358-154 | d43c02fd-9edb-449d-b70c-9a7659df4272 | 1 | 2015-03-03 |
| 33358-154-90 | EA - Each | 33358-154 | 1e9eea91-96e2-4cae-a5f7-163793318054 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [RXCHANGE CO.] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33358-154-00 | 33358015400 | 100 in 1 BOTTLE | Historical |
| 33358-154-90 | 33358015490 | 90 in 1 BOTTLE | Historical |